(100 days)
Not Found
No
The description details the use of the oscillometric method and a microprocessor to analyze pressure signals, which are standard techniques for blood pressure monitors and do not inherently involve AI/ML. There is no mention of AI, ML, DNN, or training/test sets.
No
The device is described as a "Blood Pressure Monitor" intended for "measuring blood pressure and pulse rate," which are diagnostic functions, not therapeutic.
Yes
The device is a blood pressure monitor, which measures blood pressure and pulse rate. The "Intended Use / Indications for Use" section explicitly states its purpose is "measuring blood pressure and pulse rate," and the "Device Description" details how it determines "systolic and diastolic blood pressure and calculating pulse rate." These measurements provide information about a patient's physiological state, which is indicative of a diagnostic function.
No
The device description explicitly states that the main components are the "main unit and cuff unit," which are hardware components. It also mentions a microprocessor, pressure sensor, operation keys, electromagnetic deflation control valve, and LCD, all of which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device is a Blood Pressure Monitor. It measures blood pressure and pulse rate non-invasively by applying a cuff to the upper arm. It uses an electronic pressure sensor and the oscillometric method to analyze pressure changes in the cuff.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the body. It directly interacts with the body externally to obtain measurements.
Therefore, since the device does not perform tests on in vitro samples, it does not fit the definition of an In Vitro Diagnostic. It is a non-invasive medical device for measuring physiological parameters.
N/A
Intended Use / Indications for Use
This Blood Pressure Monitor is intended for use in measuring blood pressure and pulse rate in patients with arm circumferences from 16 to 36 cm (6.3 to 14.1 inch), 22 to 42cm (8.6 to 16.5 inch), 22 to 45cm (8.6 to 17.7 inch) or 40 to 52cm (15.7 to 20.5 inch).
Cuff model AC1636-01, arm circumference range is 16-36cm (6.3 to 14.1 inch), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or preeclampsia.
Cuff model AC2245-021, arm circumference range is 2245cm (8.6 to 17.7 inch), which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia. Cuff model AC2242-41 and cuff model AC4052-04, arm circumference range are 22-42cm (8.6 to 16.5 inch) and 4052cm (15.7 to 20.5 inch) respectively, which are intended for adults without conditions of diabetes, pregnancy, or pre-eclampsia.
It is intended indoor use only.
Product codes
DXN
Device Description
The Blood Pressure Monitor is designed to measure the systolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor is the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 160mm and 520 mm, includes the inflatable bladder and polyester shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the electromagnetic deflation control valve and the LCD.
The devices embed a Cellular Wireless network connections module that allows it to connect to receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse rate, date and time by Wireless method and protocol.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper Arm
Indicated Patient Age Range
children older than 3 years old or adults
Intended User / Care Setting
Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The first clinical study (AC2242-41) was performed using 86 subjects, collecting 258 datasets. The second clinical study (AC4052-04) was performed using 86 subjects, collecting 258 datasets. The data source for both studies consisted of general adult subjects. The studies aimed to validate the accuracy of the device according to ANSI/AAMI/ISO 81060-2:2019 and ISO 81060-2:2018/Amd.1:2020. No specific annotation protocol was described beyond the collection of systolic BP (SBP) and diastolic BP (DBP) data.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing: Conducted in accordance with FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1. Tests included Cytotoxicity, Sensitization, and Irritation. The device is considered surface contacting for a duration not exceeding 24 hours.
Non-clinical data: The subject device was tested according to IEC 60601-1, IEC 60601-1-2, IEC 80601-2-30, IEC 60601-1-11, IEC 60601-1-6, IEC 62366-1, and FDA Guidance for Non-Automated Sphygmomanometer. Wireless testing (GSM and LTE) was conducted according to FCC 47 CFR Part22 subpart H, FCC 47 CFR Part24 subpart E, FCC 47 CFR Part27 subpart C, and the FDA guidance "Radio Frequency Wireless Technology in Medical Devices" (August 14, 2013).
Clinical data:
Two clinical studies were performed on 172 general adult subjects in total to validate the new cuff sizes (2242cm and 4052cm) in compliance with ANSI/AAMI/ISO 81060-2:2019 and ISO 81060-2:2018/Amd.1:2020/Amd.1:2020.
- The first clinical study (AC2242-41):
- Sample size: 86 subjects, 258 datasets. Subjects aged 51.8±14.9.
- Key results: The mean differences between reference BPs and device readings were -0.02 ±2.12/0.17±1.97 mmHg for SBP / DBP (criterion 1), and -0.02±1.49/0.17±1.51 mmHg for SBP / DBP (criterion 2). The device fulfilled both validation criteria.
- The second clinical study (AC4052-04):
- Sample size: 86 subjects, 258 datasets. Subjects aged 49.9±10.2.
- Key results: The mean differences between reference BPs and device readings were -0.56±1.58/-0.24±1.63 mmHz for SBP / DBP (criterion 1), and -0.56-0.98/-0.24±1.12 mmHg for SBP/DBP (criterion 2). The device fulfilled both validation criteria.
Summary: The clinical performance results support that the differences between the subject device and the cleared device do not raise different questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Blood Pressure Measurement: 0mmHg ~ 299mmHg, 5℃ - 40℃ within ±3mmHg (0.4kPa)
Pulse rate measurement: 40-199 beat/minute, ±5%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 21, 2024
Guangdong Transtek Medical Electronics Co., Ltd. Fan Jerry RA Manager Zone A, No. 105, Dongli Road, Torch Development District Zhongshan, Guangdong, China 528437
Re: K241351
Trade/Device Name: Blood Pressure Monitor (TMB-2092-G) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 11, 2024 Received: July 31, 2024
Dear Fan Jerry:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Blood Pressure Monitor (TMB-2092-G)
Indications for Use (Describe)
This Blood Pressure Monitor is intended for use in measuring blood pressure and pulse rate in patients with arm circumferences from 16 to 36 cm (6.3 to 14.1 inch), 22 to 42cm (8.6 to 16.5 inch), 22 to 45cm (8.6 to 17.7 inch) or 40 to 52cm (15.7 to 20.5 inch).
Cuff model AC1636-01, arm circumference range is 16-36cm (6.3 to 14.1 inch), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or preeclampsia.
Cuff model AC2245-021, arm circumference range is 22~45cm (8.6 to 17.7 inch), which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia. Cuff model AC2242-41 and cuff model AC4052-04, arm circumference range are 22-42cm (8.6 to
16.5 inch) and 40~52cm (15.7 to 20.5 inch) respectively, which are intended for adults without conditions of diabetes, pregnancy, or pre-eclampsia.
It is intended indoor use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2024/7/31
1. Submission sponsor
Name: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, Guangdong, China Contact person: Jerry Fan Title: RA Manager E-mail: gt-rateam(@transtekcorp.com Tel: +86-157 2866 8528
2. Submission correspondent
Name: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, Guangdong, China Contact person: Jerry Fan E-mail: gt-rateam(@transtekcorp.com Tel: +86-157 2866 8528
| Trade/Device Name | Blood Pressure Monitor |
|---|---|
| Model | TMB-2092-G |
| Common Name | Blood Pressure Monitor |
| Regulatory Class | Class II |
| Product Code | DXN |
| Submission type | Special 510(k) |
3. Subject Device Information
Predicate Device Information 4.
| Predicate Device | |
|---|---|
| Sponsor | Guangdong Transtek Medical Electronics Co., Ltd. |
| Device Name | Blood Pressure monitor |
| Model | TMB-2092-G |
| 510(k) Number | K232621 |
| Product Code | DXN |
| Regulation Class | Class II |
The Predicate Device have not been subject to a design-related recall.
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5. Device Description
The Blood Pressure Monitor is designed to measure the systolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor is the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 160mm and 520 mm, includes the inflatable bladder and polyester shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the electromagnetic deflation control valve and the LCD.
The devices embed a Cellular Wireless network connections module that allows it to connect to receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse rate, date and time by Wireless method and protocol.
Intended use & Indication for use 6.
This Blood Pressure Monitor is intended for use in measuring blood pressure and pulse rate in patients with arm circumferences from 16 to 36 cm (6.3 to 14.1 inch), 22 to 42cm (8.6 to 16.5 inch), 22 to 45cm (8.6 to 17.7 inch) or 40 to 52cm (15.7 to 20.5 inch).
Cuff model AC1636-01, arm circumference range is 16-36cm (6.3 to 14.1 inch), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or pre-eclampsia.
Cuff model AC2245-021, arm circumference range is 22~45cm (8.6 to 17.7 inch), which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia.
Cuff model AC2242-41 and cuff model AC4052-04. arm circumference range are 2242cm (8.6 to 16.5 inch) and 4052cm (15.7 to 20.5 inch) respectively, which are intended for adults without conditions of diabetes, pregnancy, or pre-eclampsia.
It is intended indoor use only.
| Features | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Applicant | Guangdong Transtek Medical | ||
| Electronics Co., Ltd. | Guangdong Transtek Medical | ||
| Electronics Co., Ltd. | / | ||
| Trade name | Blood pressure monitor | Blood pressure monitor | / |
| Model | TMB-2092-G | TMB-2092-G | / |
| 510(k) Number | Applying | K232621 | / |
| Classification | |||
| Regulation | 21CRF 870.1130 | 21CRF 870.1130 | / |
| Features | Subject Device | Predicate Device | Remark |
| Classification and | |||
| Code | Class II, | ||
| DXN | Class II, | ||
| DXN | Same | ||
| Intended use | This Blood Pressure Monitor is | ||
| intended for use in measuring blood | |||
| pressure and pulse rate in patients | |||
| with arm circumferences from 16 to | |||
| 36 cm (6.3 to 14.1 inch), 22 to | |||
| 42cm (8.6 to 16.5 inch), 22 to 45cm | |||
| (8.6 to 17.7 inch) or 40 to 52cm | |||
| (15.7 to 20.5 inch). | |||
| Cuff model AC1636-01, arm | |||
| circumference range is 16~36cm | |||
| (6.3 to 14.1 inch), which is intended | |||
| for children older than 3 years old | |||
| or adults without conditions of | |||
| diabetes, pregnancy, or pre- | |||
| eclampsia. | |||
| Cuff model AC2245-021, arm | |||
| circumference range is 22~45cm | |||
| (8.6 to 17.7 inch), which is intended | |||
| for adult population or those who | |||
| with conditions of diabetes, | |||
| pregnancy, or pre-eclampsia. | |||
| Cuff model AC2242-41 and cuff | |||
| model AC4052-04, arm | |||
| circumference range are 22~42cm | |||
| (8.6 to 16.5 inch) and 40~52cm | |||
| (15.7 to 20.5 inch) respectively, | |||
| which are intended for adults | |||
| without conditions of diabetes, | |||
| pregnancy, or pre-eclampsia. | |||
| It is intended indoor use only. | This Blood Pressure Monitor is | ||
| intended for use in measuring blood | |||
| pressure and pulse rate in patients | |||
| with arm circumferences from 16 to | |||
| 36 cm (6.3 to 14.1 inch) or 22 to | |||
| 45cm (8.6 to 17.7 inch). | |||
| Cuff model AC1636-01, arm | |||
| circumference range is 16~36cm | |||
| (6.3 to 14.1 inch), which is intended | |||
| for children older than 3 years old | |||
| or adults without conditions of | |||
| diabetes, pregnancy, or pre- | |||
| eclampsia. | |||
| Cuff model AC2245-021, arm | |||
| circumference range is 22~45cm | |||
| (8.6 to 17.7 inch), which is intended | |||
| for adult population or those who | |||
| with conditions of diabetes, | |||
| pregnancy, or pre-eclampsia. | |||
| It is intended indoor use only. | Different | ||
| Note 1 | |||
| Patient | |||
| Populations | at least 3 years of age or older | at least 3 years of age or older | Same |
| Principle | This product uses the Oscillometric | ||
| Measuring method to detect blood | |||
| pressure. | |||
| Before every measurement, the unit | |||
| establishes a "zero pressure" | This product uses the Oscillometric | ||
| Measuring method to detect blood | |||
| pressure. | |||
| Before every measurement, the unit | |||
| establishes a "zero pressure" | Same | ||
| Features | Subject Device | Predicate Device | Remark |
| equivalent to the atmospheric | |||
| pressure. Then it starts inflating the | |||
| arm cuff, meanwhile, the unit | |||
| detects pressure oscillations | |||
| generated by beat-to-beat pulsatile, | |||
| which is used to determine the | |||
| systolic and diastolic pressure, and | |||
| also pulse rate. | equivalent to the atmospheric | ||
| pressure. Then it starts inflating the | |||
| arm cuff, meanwhile, the unit | |||
| detects pressure oscillations | |||
| generated by beat-to-beat pulsatile, | |||
| which is used to determine the | |||
| systolic and diastolic pressure, and | |||
| also pulse rate. | |||
| Anatomical sites | Upper Arm | Upper Arm | Same |
| Where used | |||
| (hospital, home, | |||
| ambulance, etc.) | Home | Home | Same |
| Energy used and / | |||
| or delivered | Battery mode: 6VDC (4 * 1.5V | ||
| batteries) | |||
| AC adapter mode: Input 100–240V, | |||
| 50-60Hz, 0.2A max; Output 6VDC, | |||
| 1 A | Battery mode: 6VDC (4 * 1.5V | ||
| batteries) | |||
| AC adapter mode: Input 100–240V, | |||
| 50-60Hz, 0.2A max; Output 6VDC, | |||
| 1 A | Same | ||
| Human factors | Blood pressure | Blood pressure | Same |
| Performance | Measuring systolic and diastolic | ||
| blood pressure and pulse rate of | |||
| patients at least 3 years of age or | |||
| older, including irregular pulse | |||
| rhythm detection | Measuring systolic and diastolic | ||
| blood pressure and pulse rate of | |||
| patients at least 3 years of age or | |||
| older, including irregular pulse | |||
| rhythm detection | Same | ||
| Biocompatibility | Cuff, according to ISO-10993 | Cuff, according to ISO-10993 | Same |
| Operation | Temperature: 5 ℃~ 40 ℃ | Temperature: 5 ℃~ 40 ℃ | Same |
| Environment | Relative Humidity: 15%~90%RH, | ||
| Atmospheric Pressure: | |||
| 70KPa~106KPa. | Relative Humidity: 15%~90%RH, | ||
| Atmospheric Pressure: | |||
| 70KPa~106KPa. | Same | ||
| Storage and | |||
| transportation | |||
| environment | Temperature: -4°F to +140°F (- | ||
| 20°C to +60°C) | |||
| Relative humidity: ≤93%, non- | |||
| condensing, at a water vapour | |||
| pressure up to 50hPa | |||
| Atmospheric pressure: 500hPa to 1 | |||
| 060hPa | Temperature: -4°F to +140°F (- | ||
| 20°C to +60°C) | |||
| Relative humidity: ≤93%, non- | |||
| condensing, at a water vapour | |||
| pressure up to 50hPa | |||
| Atmospheric pressure: 500hPa to 1 | |||
| 060hPa | Same | ||
| Electrical safety | According to IEC60601-1-2 | ||
| According to IEC60601-1 | According to IEC60601-1-2 | ||
| According to IEC60601-1 | Same | ||
| Blood Pressure | |||
| Measurement | 0mmHg ~ 299mmHg, | ||
| 5℃ - 40℃ within ±3mmHg | 0mmHg ~ 299mmHg, | ||
| 5℃ - 40℃ within ±3mmHg | Same | ||
| Features | Subject Device | Predicate Device | Remark |
| (0.4kPa) | (0.4kPa) | ||
| Pulse rate | |||
| measurement | 40-199 beat/minute, ±5% | 40 ~ 199 beat/minute, ±5% | Same |
| Cuff Deflation | Automatic deflation | Automatic deflation | Same |
| Memory Size | 500 | 500 | Same |
| Wireless | GSM, LTE | GSM, LTE | Same |
Comparison to the Predicate Device 7.
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7
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Justification of difference:
Note 1:
The subject device has the same functions and principle with cleared device (K232621). The modification that was occurred is only add two cuff sizes, 2242cm and 4052cm, both of them are for the general population use. In addition, the subject device has been verified according to IEC 60601-1-11 and IEC 60601-1-6, and it also has been validated according to ISO 80601-2-30 and ISO 81060-2. Thus, the differences between the subject device and the cleared device do not raise different questions of safety and effectiveness.
9
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- . Cytotoxicity
- Sensitization .
- . Irritation
The subject device is considered surface contacting for a duration of not exceed 24 hours.
Non-clinical data
The subject device has been tested according to the following standards:
- . IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and essential performance
- . IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- . IEC 80601-2-30: Medical electrical equipment - Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.
- . IEC 60601-1-11: Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . IEC 60601-1-6: Medical Electrical Equipment - Part 1-6: General requirements for safety – Collateral Standard: Usability.
- . IEC 62366-1: Medical devices – Application of usability engineering to medical devices.
- . FDA Guidance for Non-Automated Sphygmomanometer.
Wireless testing:
- GSM and LTE test according to FCC 47 CFR Part22 subpart H, FCC 47 CFR Part24 subpart E, FCC 47 CFR Part27 subpart C.
- Radio Frequency Wireless Technology in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (August 14, 2013)
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Clinical data
Blood pressure monitor with its new cuff sizes are 2242cm and 4052cm, these clinical tests were performed and comply with the accuracy requirements of ANSI/AAMI/ISO 81060-2:2019 Non- invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type and ISO 81060-2:2018/Amd.1:2020 Non- invasive sphygmomanometers —Part 2: Clinical investigation of intermittent automated measurement type AMENDMENT 1. Two clinical studies of this device consisted of 172 general adult subjects.
The first clinical study (AC2242-41)
The clinical study aimed to validate the accuracy of TMB-2092-G blood pressure monitor with cuff AC2242-41. 258 datasets were collected from 86 subjects. There are 86 adult subjects with aged 51.8±14.9. The mean differences between reference BPs and device readings were -0.02 ±2.12/0.17±1.97 mmHg for systolic BP (SBP) / diastolic BP (DBP) of criterion 1, and -0.02±1.49/0.17±1.51 mmHg for SBP / DBP of criterion 2. TMB-2092-G with armbands of 22.0-42.0 cm fulfilled both validation criteria 1 and 2 of ANSI/AAMI/ISO 81060-2:2019 and ISO 81060-2:2018/Amd.1:2020.
The second clinical study (AC4052-04)
The clinical study aimed to validate the accuracy of TMB-2092-G blood pressure monitor with cuff AC4052-04. 258 datasets were collected from 86 subjects with aged 49.9±10.2. The mean differences between reference BPs and device readings were -0.56±1.58/-0.24±1.63 mmHz for systolic BP (SBP) / diastolic BP (DBP) of criterion 1. and -0.56-0.98/-0.24±1.12 mmHg for SBP/DBP of criterion 2. TMB-2092-G with armbands of 40.0-52.0 cm fulfilled both validation criteria 1 and 2 of ANSVAAMI/ISO 81060-2:2019 and ISO 81060-2:2018/Amd.1:2020.
Summary
Based on the clinical performance in the clinical studies, the differences between the subject device and the cleared device do not raise different questions of safety and effectiveness.
9. Conclusion
The subject device is itself of the corresponding cleared device manufactured by Guangdong Transtek Medical Electronics Co., Ltd. (FDA 510(k) number: K232621). The addition of new arm-cuff range, 2242cm and 4052cm, will not affect the intended use or alter the fundamental scientific technology of the device. So, the conclusion is that the subject device is substantial equivalent to the cleared device.